86346 Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Notices 

I. General Description of the Genetic 

Metabolic Diseases Advisory 

Committee’s Duties 

The Committee reviews and evaluates 

data on the safety and effectiveness of 

marketed and investigational human 

drug and biologic products for use in 

the treatment of genetic metabolic 

diseases and makes appropriate 

recommendations to the Commissioner 

of Food and Drugs. 

II. Qualifications 

Persons nominated for the Committee 

should be full-time employees of firms 

that develop human drug and biologic 

products, or consulting firms that 

represent human drug and biologic 

product developers or have similar 

appropriate ties to industry. 

III. Selection Procedure 

Any industry organization interested 

in participating in the selection of an 

appropriate nonvoting member to 

represent industry interest must send a 

letter stating that interest to the FDA 

contact (see FOR FURTHER INFORMATION

CONTACT) within 30 days of publication 

of this document (see DATES). Within the 

subsequent 60 days, FDA will send a 

letter to each organization that has 

expressed an interest, attaching a 

complete list of all such organizations; 

and a list of all nominees along with 

their current re ́sume ́s or curriculum 

vitae. The letter will also state that it is 

the responsibility of the interested 

organizations to confer with one another 

and to select a candidate, to represent 

industry interest for the committee, 

within 60 days after the receipt of the 

FDA letter. The interested organizations 

are not bound by the list of nominees in 

selecting a candidate. However, if no 

individual is selected within 60 days, 

the Commissioner will select temporary 

nonvoting members to represent 

industry interests. 

IV. Nomination Procedure 

Individuals may self-nominate and/or 

an organization may nominate one or 

more individuals to serve as a 

temporary nonvoting industry 

representative. Nominations must 

include a cover letter and a current, 

complete re ́sume ́ or curriculum vitae for 

each nominee, including current 

business and/or home address, 

telephone number, and email address if 

available; and a signed copy of the 

Acknowledgement and Consent form 

available at the FDA Advisory 

Committee Membership Nomination 

Portal (see ADDRESSES). Nominations 

should specify the advisory committee 

for which the nominee is recommended 

within 60 days of publication of this 

document (see DATES). Nominations 

should also acknowledge that the 

nominee is aware of the nomination, 

unless self-nominated. FDA will 

forward all nominations to the 

organizations expressing interest in 

participating in the selection process for 

the committee. Only interested industry 

organizations participate in the 

selection process. Persons who 

nominate themselves as nonvoting 

industry representatives will not 

participate in the selection process. 

FDA seeks to include the views of 

members of all gender groups, members 

of all racial and ethnic groups, and 

individuals with and without 

disabilities on its advisory committees 

and, therefore encourages nominations 

of appropriately qualified candidates 

from these groups. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. 1001 et seq.) and 21 CFR part 14, 

relating to advisory committees. 

Dated: December 7, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–27303 Filed 12–12–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Information 

Collection Request Title: Applications 

for Deemed Public Health Service 

Employment With Liability Protections 

Under the Federal Tort Claims Act for 

Health Centers, Deemed Health Center 

Volunteers, and Free Clinic Sponsored 

Individuals, OMB No. 0906–XXXX–New 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than February 12, 

2024. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 14N39, 5600 Fishers 

Lane, Rockville, Maryland 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Joella Roland, the HRSA 

Information Collection Clearance 

Officer, at (301) 443–3983. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the ICR title 

for reference. 

Information Collection Request Title: 

Applications for Deemed Public Health 

Service (PHS) Employment with 

Liability Protections Under the Federal 

Tort Claims Act (FTCA) for Health 

Centers, Deemed Health Center 

Volunteers, and Free Clinic Sponsored 

Individuals, OMB No. 0906–XXXX– 

New. 

Abstract: Section 224(g)–(n) of the 

PHS Act (42 U.S.C. 233(g)–(n)) states 

that entities receiving funds under 

section 330 of the PHS Act and 

specified individuals of that entity may 

be deemed to be PHS employees for the 

purpose of eligibility for liability 

protections, including FTCA coverage, 

for the performance of medical, surgical, 

dental, and related functions within the 

scope of deemed employment upon 

approval of an application for deemed 

employment. The Health Center 

Program and Health Center FTCA 

Program are administered by HRSA. 

Health centers submit deeming 

applications annually to HRSA in the 

prescribed form and manner in order to 

obtain deemed PHS employee status, 

with the associated eligibility for FTCA 

coverage. Such applications must be 

approved by HRSA in a Notice of 

Deeming Action. Deemed health centers 

must resubmit applications annually 

meeting all deeming requirements in 

order to maintain deemed status. 

Volunteer Health Professionals (VHPs) 

Section 224(q) of the PHS Act (42 

U.S.C. 233(q)) extends eligibility for 

deemed PHS employee status to VHPs 

sponsored by deemed health centers 

upon approval of an individual 

sponsorship application for deemed 

PHS employment. The Health Center 

VHP FTCA Program is administered by 

HRSA. In order to maintain deemed 

status for VHPs, deemed health centers 

must submit to HRSA an annual 

deeming sponsorship application on 

behalf of individually named VHPs. For 

liability protections to apply, such 


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Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Notices 86347 

applications must be approved by HRSA 

in a Notice of Deeming Action 

applicable to the individual VHP, 

which, absent other intervening facts, 

generally is applicable to covered 

activities within the scope of such 

deemed PHS employment for a calendar 

year. 

Free Clinics 

Section 224(o) of the PHS Act (42 

U.S.C. 233(o)) extends eligibility for 

deemed PHS employee status to free 

clinic health professionals, including 

employees, officers, board members, 

contractors, and volunteer health 

professionals, at qualifying free clinics. 

The Free Clinics FTCA Program is 

administered by HRSA. Free clinics 

must submit deeming sponsorship 

applications to HRSA in the specified 

form and manner on behalf of named 

individuals for HRSA’s review and 

approval. In order to continue to 

participate in the Free Clinics FTCA 

Program and maintain deemed status for 

individuals, free clinics must submit to 

HRSA an annual deeming sponsorship 

application on behalf of named 

individuals. For liability protections to 

apply, such applications must be 

approved by HRSA in a Notice of 

Deeming Action applicable to the 

sponsored individual, which, absent 

other intervening facts, generally is 

applicable to covered activities within 

the scope of such deemed PHS 

employment for a calendar year. 

Approvals are reflected, resulting in a 

‘‘deeming determination’’ that includes 

associated FTCA coverage for these 

individuals. 

HRSA proposes combining the three 

existing ICRs for these programs into a 

single ICR consisting of the three 

application forms. The three existing 

ICRs are: (1) Application for Health 

Center Program Recipients for Deemed 

PHS Employment with Liability 

Protections Under the FTCA (OMB No. 

0906–0035); (2) Application for Deemed 

Health Center Program Award 

Recipients to Sponsor VHPs for Deemed 

PHS Employment (OMB No. 0915– 

0032); and (3) FTCA Program Deeming 

Sponsorship Applications for Free 

Clinics (OMB No. 0915–0293). HRSA 

recognizes that the content of these 

three FTCA applications differs but 

proposes combining these three separate 

ICRs in order to increase efficiencies, 

decrease burden on stakeholders, and 

allow commentors to provide feedback 

more easily where applicable to 

commonalities that may impact all three 

ICRs. Pursuant to Section 224(g)–(o), 

and (q) of the PHS Act (42 U.S.C. 

233(g)–(o) and (q)), as amended, all 

three collections are done for the 

purpose of collecting information from 

certain health centers that receive grant 

funding under Section 330 of the PHS 

Act and free clinics to determine 

eligibility for liability protections, 

including FTCA coverage. Applications 

for these programs must be submitted 

through HRSA’s web-based application 

system, the Electronic Handbooks. 

These electronic application forms 

decrease the time and effort required to 

complete the older, paper-based OMB 

approved FTCA application forms. In 

order to make the terminology more 

consistent, the names of the 

applications are now as follows: (1) 

Application for Health Center Program 

Recipients for Deemed PHS 

Employment with Liability Protections 

Under the FTCA; (2) Application for 

Deemed Health Center Program 

Recipients to Sponsor VHPs for Deemed 

PHS Employment with Liability 

Protections Under the FTCA; and (3) 

Application for Free Clinics to Sponsor 

Individuals for Deemed PHS 

Employment with Liability Protections 

Under the FTCA. In this single ICR, 

HRSA proposes updating the content of 

the applications forms, which OMB has 

previously approved as three individual 

ICRs. The revisions are described below. 

Proposed Revisions 

1. Application for Health Center 

Program Recipients for Deemed PHS 

Employment With Liability Protections 

Under the FTCA 

HRSA is proposing several changes to 

the content of the Application for 

Health Center Program Recipients for 

Deemed PHS Employment with 

Liability Protections Under the FTCA, to 

be used for health center deeming 

applications for calendar year (CY) 2024 

and thereafter, to improve question 

clarity and clarify required 

documentation. The application 

includes: Contact Information, Section 

1: Review of Risk Management Systems, 

Section 2: Quality Improvement/Quality 

Assurance, Section 3: Credentialing and 

Privileging, Section 4: Claims 

Management, and Section 5: Additional 

Information, Certification, and 

Signatures. In addition to minor changes 

made for clarity, the application 

includes the following proposed 

changes: 

• A disclaimer regarding training for 

health center staff was added to the 

beginning of the Review of Risk 

Management Systems, Quality 

Improvement/Quality Assurance, 

Credentialing and Privileging, and 

Claims Management sections. 

Review of Risk Management Systems: 

• Questions related to required FTCA 

trainings for Obstetrics, Infection 

Control, the Health Insurance Portability 

and Accountability Act, and other 

specific areas of risk were separated into 

four questions, and detailed guidance 

for Obstetrics training was added for 

clarity. 

• To facilitate the verification of 

compliance with training requirements, 

applicants will be required to enter their 

training tracking information in a Word 

or PDF document that will be part of the 

information collection tool. 

• To enhance clarity and ensure 

accurate uploading of information, the 

quarterly assessments have been 

divided into four separate questions. 

This change aims to outline the required 

elements and information necessary for 

each risk assessment. 

Credentialing and Privileging: 

• The credentialing and privileging 

section was revised to include 

clarification regarding policy and 

procedure requirements for temporary 

privileging. 

• A new attestation question was 

added to clearly outline the 

requirements of Chapter 5 of the Health 

Center Compliance Manual, Clinical 

Staffing regarding for Credentialing and 

Privileging of health care practitioners. 

• A new question was added to 

ensure health centers ensure 

credentialing and privileging for all 

provider types, including Licensed 

Independent Practitioners, Other 

Licensed or Certified Practitioners, and 

Other Clinical Staff. 

Claims Management: 

• A new claims management question 

was added to ensure documents relating 

to potential tort claims are in the correct 

format when transmitted to the 

Department of Health and Human 

Services, Office of the General Counsel’s 

General Law Division. 

2. Application for Deemed Health 

Center Program Recipients To Sponsor 

VHPs for Deemed PHS Employment 

With Liability Protections Under the 

FTCA 

HRSA is proposing several changes to 

the content of the Application for 

Deemed Health Center Program 

Recipients to Sponsor VHPs for Deemed 

PHS Employment with Liability 

Protections Under the FTCA, to be used 

for deeming sponsorship applications 

for CY 2024 and thereafter, to improve 

question clarity, clarify required 

documentation, and support HRSA’s 

analysis and understanding of program 

impact. The application includes the 

following sections: Acknowledgments of 

Deemed Status Requirements, 

Acknowledgment of Required 


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86348 Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Notices 

Performance Conditions, and 

Information on the Volunteers 

Sponsored for Deeming. Specifically, 

the application includes the following 

proposed changes: 

• Volunteers Sponsored for Deeming: 

A new question has been added to better 

assist health centers sponsoring VHPs 

who perform activities during declared 

emergencies. The question asks if the 

submitted application relates to services 

provided during a declared emergency. 

• Credentialing and Privileging: 

Language has been added to ensure 

grantees understand the 2-year 

requirement for credentialing and 

privileging. 

3. Application for Free Clinics To 

Sponsor Individuals for Deemed PHS 

Employment With Liability Protections 

Under the FTCA 

HRSA is proposing several changes to 

the content of the Applications for Free 

Clinics to Sponsor Individuals for 

Deemed PHS Employment with 

Liability Protections Under the FTCA, to 

be used for deeming sponsorship 

applications for CY 2024 and thereafter, 

to improve question clarity and clarify 

required documentation. Specifically, 

the application includes the following 

proposed changes: 

• In Section III, ‘‘Sponsoring Free 

Clinic Eligibility,’’ a note was added to 

clarify the non-profit status 

documentation requirements for free 

clinics; and 

• In Section VII, ‘‘Patient Visit Data,’’ 

clarifying language was added to ensure 

that free clinics provide precise and 

accurate data. 

Need and Proposed Use of the 

Information: Deeming applications must 

address certain specified criteria 

required by law to be approved, and 

FTCA application forms are critical to 

HRSA’s deeming determination process. 

The application submissions provide 

HRSA with the information essential to 

evaluate the application and make a 

deeming determination. Moreover, the 

application information is also used to 

determine whether a site visit is 

appropriate to assess issues relating to 

quality of care and to determine 

technical assistance needs. 

Likely Respondents: Respondents 

include Health Center Program funding 

recipients seeking deemed PHS 

employee status for purposes of 

eligibility for liability protections, 

including FTCA coverage; Health Center 

Program funding recipients that have 

been deemed as PHS employees and 

that seek to sponsor VHPs for deemed 

PHS employee status for purposes of 

eligibility for liability protections, 

including FTCA coverage; and free 

clinics that seek to sponsor individuals 

for deemed PHS employee status for 

purposes of eligibility for liability 

protections, including FTCA coverage. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose, or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install, and utilize 

technology and systems for the purpose 

of collecting, validating and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total 

burden 

hours 

Application for Health Center Program Recipients for Deemed PHS Employment with Liability Protections Under the FTCA ............................... 1,160 1 1,160 2.5 2,900 

Application for Deemed Health Center Program Recipients to Sponsor 

Volunteer Health Professionals (VHPs) for Deemed PHS Employment 

with Liability Protections Under the FTCA ............................................... 1,156 3 3,468 2.0 6,936 

Application for Free Clinics to Sponsor Individuals for Deemed PHS Employment with Liability Protections Under the FTCA ............................... 374 3 1,122 2.0 2,244 

Total ...................................................................................................... 2,655 7 5,705 9 12,080 

HRSA specifically requests comments 

on (1) the necessity and utility of the 

proposed information collection for the 

proper performance of the agency’s 

functions, (2) the accuracy of the 

estimated burden, (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and (4) the 

use of automated collection techniques 

or other forms of information 

technology to minimize the information 

collection burden. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2023–27362 Filed 12–12–23; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Announcement of the Fourth Meeting 

of the 2025 Dietary Guidelines 

Advisory Committee 

AGENCY: Office of Disease Prevention 

and Health Promotion, Department of 

Health and Human Services (HHS), 

Office of the Assistant Secretary for 

Health (OASH); Department of 

Agriculture (USDA), Food, Nutrition, 

and Consumer Services (FNCS). 

ACTION: Notice. 

SUMMARY: The Departments of Health 

and Human Services and Agriculture 

announce the fourth meeting of the 2025 

Dietary Guidelines Advisory Committee 

(Committee). This meeting will be open 

to the public virtually. 

DATES: The fourth Committee meeting 

will be held on January 19, 2024, from 

8:30 a.m. to 3:00 p.m. Eastern Time. 

ADDRESSES: The meeting will be 

accessible online via livestream and 

recorded for later viewing. Registrants 

will receive the livestream information 

prior to the meeting. 

FOR FURTHER INFORMATION CONTACT: 

Designated Federal Officer, 2025 Dietary 

Guidelines Advisory Committee, Janet 

M. de Jesus, MS, RD; Office of Disease 

Prevention and Health Promotion, 1101 

Wootton Parkway, Suite 420, Rockville, 

MD 20852; Phone: 240–453–8266; Email 

DietaryGuidelines@hhs.gov. Additional 

information is at DietaryGuidelines.gov. 


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